CompletedPhase 2

A Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's Disease

A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter, Phase II Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's Disease

Lead sponsor

Genentech, Inc.

Asset

Crenezumab

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 18-26•AD symptomatic therapy: stable ≥2 months

Primary endpoint

•Brain amyloid load

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDABE4955g

Secondary IDGN00762Hoffmann-La Roche

NCT IDNCT01397578

Timeline

Milestones

Study first posted2011-07-19estimated

Study start2011-08-31actual

Primary completion2014-04-30actual

Study completion2014-04-30actual

Last update posted2017-07-12actual

Assets

Drug assets

Crenezumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorder Association (NINCDS-ADRDA) criteria

•Mini-Mental State Examination (MMSE) score of 18-26 points at screening

•Geriatric Depression Scale (GDS-15) score of < 6

•Completion of 6 years of education (or good work history consistent with exclusion of mental retardation or other pervasive developmental disorders)

•For patients currently receiving treatment with approved AD treatments (AChE inhibitors or memantine): Treatment initiated and continued for at least the last 3 months prior to randomization, at a stable dose for at least the last 2 months prior to randomization

Exclusion criteria

•Severe or unstable medical condition that, in the opinion of the investigator or Sponsor, would interfere with the patient's ability to complete the study assessments or would require the equivalent of institutional or hospital care

•History or presence of clinically evident vascular disease potentially affecting the brain (e.g., stroke, clinically significant carotid or vertebral stenosis or plaque, aortic aneurysm, intracranial aneurysm, cerebral hemorrhage, arteriovenous malformation)

•History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system trauma (e.g., cerebral contusion)

•Hospitalization within 4 weeks prior to screening

•Previous treatment with MABT5102A or any other therapeutic that targets Abeta

•Treatment with any biologic therapy within 5 half-lives or 3 months prior to screening, whichever is longer, with the exception of routinely recommended vaccinations, which are allowed

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Amyloid biomarkers

Neuroimaging

Fluid / digital biomarkers

Global cognition

1 endpoint

Secondary/protocol endpoint

Change in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS Cog) score

Time frame:Baseline to Week 73

ADAS-Cog

change from baseline, improvement

Amyloid biomarkers

1 endpoint

Primary/protocol endpoint

Change in brain amyloid load as assessed by amyloid PET imaging

Time frame:Baseline to Week 69

change from baseline, improvement

Neuroimaging

1 endpoint

Secondary/protocol endpoint

Change in brain metabolism as assessed by 18F-fluorodeoxyglucose positron emission tomography (FDG PET) imaging

Time frame:Baseline to Week 69

change from baseline, improvement

Fluid / digital biomarkers

1 endpoint

Secondary/protocol endpoint

Changes in cerebrospinal fluid (CSF) biomarkers relevant to Alzheimer's disease

Time frame:Baseline to Week 69

descriptive

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.